A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism

Официальное название

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

Обзор

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Вмешательства

• Препарат KarXT
  Specified dose on specified days
• Препарат KarX-EC
  Specified dose on specified days
• Препарат KarXT + KarX-EC Matching Placebo
  Specified dose on specified days

Первичные конечные точки

• Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8 [Срок оценки: Week 8]

Вторичные конечные точки (12)

• Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8 [Срок оценки: Week 8]
• Number of Participants With ABC-I Response at Week 8 [Срок оценки: Week 8]
• Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8 [Срок оценки: Week 8]
• Change From Baseline on the Stereotypic Behavior Subscale at Week 8 [Срок оценки: Week 8]
• Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8 [Срок оценки: Week 8]
• Change From Baseline on the Inappropriate Speech Subscale at Week 8 [Срок оценки: Week 8]
• Clinical Global Impression-Improvement (CGI-I) Score at Week 8 [Срок оценки: Week 8]
• Number of Participants With Procholinergic Symptoms [Срок оценки: Up to approximately 12 weeks]
• Number of Participants With Anticholinergic Symptoms [Срок оценки: Up to approximately 12 weeks]
• Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 12 weeks]
• Number of Participants With Serious Adverse Events (SAEs) [Срок оценки: Up to approximately 12 weeks]
• Number of Participants With Adverse Events of Special Interest (AESIs) [Срок оценки: Up to approximately 12 weeks]

Критерии участия

Критерии включения

• Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.
• Participants must have ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).

Критерии исключения

• Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).
• Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
• Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
• Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
• Other protocol-defined Inclusion/Exclusion criteria may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 26 центров

• Local Institution - 0036 — Dothan
• Local Institution - 0236 — Phoenix
• Local Institution - 0031 — Anaheim
• Local Institution - 0257 — Glendale
• Local Institution - 0233 — Redlands
• Local Institution - 0181 — San Rafael
• Local Institution - 0252 — Colorado Springs
• Local Institution - 0264 — Boca Raton
• … и ещё 18 центров

Канада · 5 центров

• Local Institution - 0289 — Airdrie
• Local Institution - 0136 — Edmonton
• Local Institution - 0135 — Kingston
• Local Institution - 0205 — Toronto
• Local Institution - 0187 — Montreal

Австралия · 4 центра

• Local Institution - 0010 — Westmead
• Local Institution - 0007 — Brisbane
• Local Institution - 0045 — Melbourne
• Local Institution - 0286 — Melbourne

Идентификаторы

NCT: NCT07284745 · CN012-0044 · 2025-523189-26-00 · U1111-1325-4950

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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